Finerenone Treatment for Diabetic Cardiovascular Autonomic Neuropathy: the FibroCAN Study

Phase 2RecruitingNCT06906081

Peter Rossing100 enrolled

Overview

Diabetic neuropathy is a serious and common complication of diabetes that currently has no cure. One form of this condition is cardiovascular autonomic neuropathy (CAN), which affects about 20% of people with diabetes-an estimated 100 million people worldwide. CAN is a significant risk factor for death and health problems like heart disease and kidney damage, and may contribute to the high rates of cardiovascular-related deaths in people with diabetes. This study is a double-blind, randomized, placebo-controlled, two-center trial. The study aims to test whether finerenone can treat cardiovascular autonomic neuropathy in patients with type 2 diabetes. The trial will evaluate the effects of 78 weeks of treatment with finerenone or a placebo, assigned randomly in a 1:1 ratio, on early-stage cardiovascular autonomic neuropathy. The trial will include 100 participants with type 2 diabetes. Additionally, the study will investigate how the treatment impacts other types of neuropathy and related pathological mechanisms.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

100

Conditions

Cardiovascular Autonomic Neuropathy Type 2 Diabetes Diabetic Neuropathies

Interventions

Kerendia (Finerenone, BAY94-8862)DRUG

Titration of finerenone will be based on baseline eGFR. Participants with eGFR \> 60 mL/min/1.73m² will start on a 20mg dosage. Medication dosage will be increased to 40 mg after one month if serum potassium \< 4.8 mmol/l. If side effects occur at any dosage, the dosage will be reduced to the previous level. Participants with eGFR \< 60 and \>25 Participants with eGFR \< 60 mL/min/1.73m² (and eGFR \< 25 mL/min/1.73m²) will start on a 10mg dosage. Medication dosage will be increased to 20 mg after one month if serum potassium \< 4.8 mmol/l. Subsequently, Medication dosage will be increased to 40 mg after an additional one month if serum potassium \< 4.8 mmol/l. If side effects occur at any dosage, the dosage will be reduced to the previous level. Finerenone is administered orally as immediate release tablets.

PlaceboDRUG

Placebo tablets matching BAY94-8862 are administered orally.

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

To be included in this study the participants must fulfill the following inclusion criteria. * Given informed consent * Type 2 diabetes defined by WHO criteria * Aged 40 ≥ at inclusion * Pathological E/I ratio (Mean value of three measures) Exclusion criteria Participants will be excluded in one or more of the following criteria are met. * No CAN (no abnormal CARTs) * Definite CAN (more than one abnormal CART) * HbA1C \>100 mmol/L * Treatment with potassium-sparing diuretics (amiloride) or MRAs e.g., spironolactone or eplerenone which cannot be discontinued 4 weeks prior to screening visit. The patient's primary physician, who is not involved in this study, will determine if discontinuation is possible. * Atrial fibrillation/flutter * Congestive heart failure (NYHA class 3-4) * History of cardiac arrhythmia * Severe forms of respiratory disease including asthma and COPD * Any nondiabetic cause of neuropathy * All female subjects of childbearing potential (WOCBP) must have a negative result of a highly sensitive urine HCG (pregnancy test) performed at screening. Subjects of childbearing potential must agree to use a highly effective form of contraception throughout the duration of the study (list of definition on WOCBP and accepted contraception in appendix A). * Severe hepatic impairment * Lactose intolerance * Breastfeeding * Nephropathy requiring dialysis * Beta-blocker-use * Hyperkalemia at screening visit (plasma potassium \>4.8 mmol/l) * eGFR \< 25 ml/min/1.73m2 * Potassium plasma \> 4.8 mmol/l (at randomization) * Treatment with strong CYP3A4-inhibitors (e.g. Itraconazol, ketoconazol, ritonavir, cobicistat, clarithromycin) which cannot be discontinued 4 weeks prior to screening visit * Treament with moderate to strong CYP3A4-induceres (e.g. rifampicin, carbamazepine, phenytoin, phenobarbital, St John's Wort or efavirenz) which cannot be discontinued 4 weeks prior to screening visit * Have received chemotherapeutic treatment within last 12 months * Grapefruit consumption that cannot be discontinued during the study period * Inability to complete study protocol, assessed to investigator * Not able to read, write and/or understand Danish